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Monoclonal Antibodies
Prasinezumab for Early Parkinson's Disease (PADOVA Trial)
Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks therafter until end of study (approximately 28 days after the final dose)
Awards & highlights
PADOVA Trial Summary
This trial will study whether prasinezumab is effective and safe in treating early Parkinson's disease.
Who is the study for?
This trial is for people with early Parkinson's Disease (PD) who've been diagnosed for 3 months to 3 years, are on stable PD meds, and can use a smartphone app and smartwatch to track symptoms. They should be in the early stages of PD without other neurological diseases or significant health issues like uncontrolled hypertension or recent substance abuse.Check my eligibility
What is being tested?
The study tests Prasinezumab, an IV drug against a placebo in participants with early-stage PD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo. Participants must be on stable PD medication throughout the study.See study design
What are the potential side effects?
While specific side effects aren't listed here, monoclonal antibodies like Prasinezumab can cause allergic reactions, infusion-related reactions (like fever or chills), and possibly affect liver function based on required lab test monitoring.
PADOVA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's is in the early stages (I or II) without medication.
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I have been diagnosed with Parkinson's disease based on movement symptoms.
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My Parkinson's disease medication will stay the same during the study.
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I have no motor complications from Parkinson's disease.
PADOVA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
OLE: Number of Participants with Adverse Events of Special Interest (AESI)
OLE: Number of Participants with Infusion Related Reactions (IRRs)
+2 moreSecondary outcome measures
Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS
Change in Bradykinesia and Rigidity from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore
Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score
+10 morePADOVA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrasinezumabExperimental Treatment1 Intervention
Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W).
Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo as an IV infusion Q4W.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,090,806 Total Patients Enrolled
Prothena Biosciences LimitedIndustry Sponsor
7 Previous Clinical Trials
579 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,450 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had serious heart problems in the past year.I have been on stable Parkinson's disease medication for at least 3 months.My high blood pressure is not under control.I have been diagnosed with Parkinson's disease dementia.You have any reasons why you shouldn't have DaT-SPECT imaging.My Parkinson's is in the early stages (I or II) without medication.I have been diagnosed with Parkinson's disease based on movement symptoms.You are allergic to prasinezumab or have had a bad reaction to other similar medications in the past.Your recent lab tests show significant problems with your liver, kidneys, blood, or urine.My Parkinson's disease medication will stay the same during the study.I have a significant neurological condition that is not Parkinson's disease.My condition is a type of Parkinson's disease that is not the common form.I have no motor complications from Parkinson's disease.You have any medical reasons that make it unsafe for you to have a brain MRI.I was diagnosed with Parkinson's disease between 3 months and 3 years ago.You have used drugs or alcohol heavily in the past year, as determined by the study doctor. You can smoke, but you cannot use marijuana.Your brain scan shows a dopamine transporter deficit, as evaluated by the central reader.
Research Study Groups:
This trial has the following groups:- Group 1: Prasinezumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04777331 — Phase 2
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